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news.Biopure Corporation has announced that it is undertaking a revamped clinical development program and expects to further its ischemia development in heart attack patients. The company has decided to leverage into new indications from the body of research it has amassed in preclinical and clinical studies involving anemia.
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Biopure expects to move on several fronts, emphasizing clinical development in Europe. The company has also identified the next step in its ischemia clinical program and has proposed three Phase II clinical trials, which are being designed for 2008, one in heart attack patients, one to address anemia in chemotherapy patients instead of or in addition to erythropoietin stimulating agents (ESAs), and one to investigate possible improvement of quality of life in the terminally ill.
The ESA study, to be designed, would examine whether Hemopure might be useful as an alternative to or in conjunction with ESAs, such as Aranesp or Procrit, which are hormones that enhance the production of red blood cells. The proposed Hemopure study would seek safety and preliminary efficacy information using Hemopure, which is not a hormone, for erythropoietic effect.
The second proposed study would be an open-label (non-randomized) compassionate use, Phase II study expected to be coordinated by the Duke Cancer Care Research Program. Participants are expected to be patients with advanced life-limiting illness. Hemopure would be evaluated on its oxygen carrying capacity to increase perfusion and improve the quality of life in this patient population, which is typically ESA-resistant.